Coronary Heart DiseasePhase 2NCT06031844

A Study to Investigate the Efficacy, Safety, and Tolerability of DFV890 for Inflammatory Marker Reduction in Adult Participants With Coronary Heart Disease and Elevated hsCRP

A Phase 2 study testing DFV890 in people with Coronary Heart Disease, run by Novartis Pharmaceuticals at 7 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This Phase 2a clinical trial evaluated the effectiveness, safety, and tolerability of increasing dose strengths of an oral daily medication, DFV890, administered for 12 weeks, to reduce key markers of inflammation related to CVD risk, such as IL-6 and IL-18, in approximately 24 people with known heart disease and an… Read more about this study

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Coronary Heart Disease
What is being tested?: DFV890
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 24 participants
Where: 7 sitesin 2 countries
Study dates: 16 Oct 2023to 23 Dec 2024
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male and female participants aged between 18 - 85 years (inclusive) at the start of screening will be included.
Subjects must have a body mass index (BMI) within the range of 18 - 45 kg/m2. BMI = Body weight (kg) / [Height (m)]2
Documented spontaneous myocardial infarction (MI) (diagnosed according to the universal MI criteria with or without evidence of ST segment elevation) at least 30 days before the start of screening.
Participants must have hsCRP levels ≥ 2 mg/L at two timepoints during screening. Screening values must be separated by a minimum of 8 days. The initial hsCRP value must be a minimum of 30 days after the qualifying MI or after any percutaneous coronary intervention (PCI) performed separately from the qualifying MI.
For participants on statin therapy (HMG-CoA reductase inhibitor), as clinically indicated, participants must be on a stable regimen (at least 4 weeks before randomization), with no planned statin dose changes over the course of the trial treatment period. Unplanned statin dose changes during the trial treatment period may occur.

Who cannot join

Patients receiving concomitant medications that are known to be strong or moderate inducers of cytochrome CYP2C9 enzyme and/or strong inducers of CYP3A, strong inhibitors of CYP2C9 and/or strong or moderate inhibitors of CYP3A and the treatment cannot be discontinued or switched to a different medication within 5 half-lives or 1 week (whichever is longer) prior to Day 1 and for the duration of the study.
Patients with suspected or proven immunocompromised state at screening
History of ongoing, chronic, or major recurrent infectious disease, at the discretion of the investigator, at the start of screening.
Use of any biologic drugs targeting the immune system within 26 weeks of Day 1
Multi-vessel Coronary Artery Bypass Graft (CABG) surgery within the past 6 months prior to the start of screening.
Symptomatic Class IV heart failure (New York Heart Association) at the start of screening.
Planned coronary revascularization (PCI or CABG) or any other major surgical procedure during the study.

Trial locations and contacts

7 sites in 2 countries.

Country

City, postcode or hospital

7 sites in 2 countries

United States6 sites

Excel Medical Clinical Trials LLC
Boca Raton, Florida, 33434
Triad Clinical Trials LLC
Greensboro, North Carolina, 27410
UF Health Science Center
Jacksonville, Florida, 32209
Valley Clinical Trials
Northridge, California, 91325
Monument Health Clinical Research
Rapid City, South Dakota, 57701
Universal Research Group LLC
Tacoma, Washington, 98405

Other trials in United States

Canada1 site

Novartis Investigative Site
Montreal, Quebec, H1T 1C8

Other trials in Canada

About this study

Official title: A Randomized, Placebo-controlled, Parallel-group, Investigator- and Participant-blinded Phase 2a Study to Investigate the Efficacy, Safety, and Tolerability of DFV890 for Inflammatory Marker Reduction in Adult Participants With Coronary Heart Disease and Elevated hsCRP

Read the detailed description

This was a multi-center, randomized, placebo-controlled, participant- and investigator-blinded study to evaluate the efficacy, safety, and tolerability of intra-individual dose escalation of DFV890 for inflammatory marker reduction in participants with coronary heart disease and elevated hsCRP. The study consisted of a screening period of up to 60 days, a treatment period of approximately 12 weeks, an end of treatment (EOT) visit on Day 85, which was one day after the last dose on Day 84, a follow-up period of approximately 1 week and a standard safety-follow-up call approximately 30 days following the last dose.

Participants meeting all eligibility criteria were randomized in a 5:5:1:1 ratio to one of four treatment sequences (three DFV890 treatment sequences or a placebo-only sequence). The dose of DFV890 was uptitrated (according to the specific treatment sequence that the participant was assigned to) approximately every three weeks at the scheduled visits on Days 22, 43 and 64.

Conditions: Coronary Heart Disease
Being tested: DFV890, DFV890 Placebo
Keywords: DFV890, Phase 2a, coronary heart disease, elevated hsCRP
Medical subject headings: Coronary Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DFV890Drug
Oral film-coated tablets of DFV890 once daily
DFV890 PlaceboDrug
Oral film-coated tablets of DFV890 placebo once daily

Study groups in NCT06031844
Study group	Role	What they receive
Treatment Sequence 1	Experimental	On Day 1, participants received 1 tablet of DFV890 matching placebo QD. Participants continued receiving DFV890 oral placebo QD until Day 22 when they started receiving DFV890 10 mg QD. The dose of DFV890 was uptitrated to 25 mg on Day 43 and to 100 mg on Day 64. Receives: Drug: DFV890; Drug: DFV890 Placebo
Treatment sequence 2	Experimental	On Day 1, participants received 1 tablet of DFV890 matching placebo QD. Participants continued receiving DFV890 oral placebo QD until Day 22 when they started receiving DFV890 25 mg QD. The dose of DFV890 was uptitrated to 50 mg on Day 43 and to 100 mg on Day 64. Receives: Drug: DFV890; Drug: DFV890 Placebo
Treatment sequence 3	Experimental	On Day 1, participants received 1 tablet of DFV890 10 mg QD. Participants continued receiving DFV890 10 mg QD until Day 22 when they started receiving DFV890 25 mg QD. The dose of DFV890 was uptitrated to 50 mg on Day 43 and to 100 mg on Day 64. Receives: Drug: DFV890
Treatment sequence 4	Placebo comparator	On Day 1, participants received 1 tablet of DFV890 matching placebo QD. Participants continued receiving DFV890 oral placebo QD until Day 84. Receives: Drug: DFV890 Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Ratio to Baseline Serum Levels of IL-6 for DFV890 Based on an Emax Model
Serum levels of IL-6 at 3 weeks after the start of a dosing period for DFV890. The circulating serum levels of the cytokine IL-6 were measured by a validated enzyme-linked immunosorbent assay (ELISA) assay at a qualified vendor.The Emax model selected for IL-6 analysis was a model with 2 covariates (IL-6 baseline and bodyweight) and 1 random effect.
Measured: Baseline (before first dose of study drug), 3 weeks after the start of a dosing period for DFV890 (between Day 22 and Day 85, depending on treatment sequence assignment)
Ratio to Baseline Serum Levels of IL-18 for DFV890 Based on an Emax Model
Serum levels of IL-18 at 3 weeks after the start of a dosing period for DFV890. The circulating serum levels of the cytokine IL-18 were measured by a validated enzyme-linked immunosorbent assay (ELISA) assay at a qualified vendor.The Emax model selected for IL-18 analysis was a model with 2 covariates (IL-18 baseline and bodyweight) and 1 random effect.
Measured: Baseline (before first dose of study drug), 3 weeks after the start of a dosing period for DFV890 (between Day 22 and Day 85, depending on treatment sequence assignment)

Secondary outcomes (1)

Trough Plasma Concentration (Ctrough)
Ctrough is the observed plasma concentration that is just prior to the beginning of, or at the end of a dosing interval.
Measured: After the last dose of each 3-week dosing period: Day 22 pre-dose, Day 43 pre-dose, Day 64 pre-dose, or Day 85, depending on treatment sequence assignment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Oct 202323 Dec 2024

First posted11 Sep 2023
Study start16 Oct 2023
Primary completion17 Dec 2024
Study completion23 Dec 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06031844
Sponsor's protocol ID: CDFV890F12201
Status last verified: Mar 2026
First submitted: 4 Sep 2023
Last updated: 9 Apr 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Placebo-controlled, Parallel-group, Investigator- and Participant-blinded Phase 2a Study to Investigate the Efficacy, Safety, and Tolerability of DFV890 for Inflammatory Marker Reduction in Adult Participants With Coronary Heart Disease and Elevated hsCRP
ClinicalTrials.gov ID: NCT06031844
Acronym / sponsor ID: CDFV890F12201
Conditions: Coronary Heart Disease
Keywords: DFV890, Phase 2a, coronary heart disease, elevated hsCRP
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 16 Oct 2023 (actual)
Primary completion: 17 Dec 2024 (actual)
Study completion: 23 Dec 2024 (actual)
First posted: 11 Sep 2023 (actual)
Results: Posted 27 Mar 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Treatment Sequence 1	Experimental	Drug: DFV890, Drug: DFV890 PlaceboOn Day 1, participants received 1 tablet of DFV890 matching placebo QD. Participants continued receiving DFV890 oral placebo QD until Day 22 when they started receiving DFV890 10 mg QD. The dose of DFV890 was uptitrated to 25 mg on Day 43 and to 100 mg on Day 64.
Treatment sequence 2	Experimental	Drug: DFV890, Drug: DFV890 PlaceboOn Day 1, participants received 1 tablet of DFV890 matching placebo QD. Participants continued receiving DFV890 oral placebo QD until Day 22 when they started receiving DFV890 25 mg QD. The dose of DFV890 was uptitrated to 50 mg on Day 43 and to 100 mg on Day 64.
Treatment sequence 3	Experimental	Drug: DFV890On Day 1, participants received 1 tablet of DFV890 10 mg QD. Participants continued receiving DFV890 10 mg QD until Day 22 when they started receiving DFV890 25 mg QD. The dose of DFV890 was uptitrated to 50 mg on Day 43 and to 100 mg on Day 64.
Treatment sequence 4	Placebo comparator	Drug: DFV890 PlaceboOn Day 1, participants received 1 tablet of DFV890 matching placebo QD. Participants continued receiving DFV890 oral placebo QD until Day 84.

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Male and female participants aged between 18 - 85 years (inclusive) at the start of screening will be included.
Subjects must have a body mass index (BMI) within the range of 18 - 45 kg/m2. BMI = Body weight (kg) / [Height (m)]2
Documented spontaneous myocardial infarction (MI) (diagnosed according to the universal MI criteria with or without evidence of ST segment elevation) at least 30 days before the start of screening.
Participants must have hsCRP levels ≥ 2 mg/L at two timepoints during screening. Screening values must be separated by a minimum of 8 days. The initial hsCRP value must be a minimum of 30 days after the qualifying MI or after any percutaneous coronary intervention (PCI) performed separately from the qualifying MI.
For participants on statin therapy (HMG-CoA reductase inhibitor), as clinically indicated, participants must be on a stable regimen (at least 4 weeks before randomization), with no planned statin dose changes over the course of the trial treatment period. Unplanned statin dose changes during the trial treatment period may occur.

Key exclusion criteria (7 listed)

Patients receiving concomitant medications that are known to be strong or moderate inducers of cytochrome CYP2C9 enzyme and/or strong inducers of CYP3A, strong inhibitors of CYP2C9 and/or strong or moderate inhibitors of CYP3A and the treatment cannot be discontinued or switched to a different medication within 5 half-lives or 1 week (whichever is longer) prior to Day 1 and for the duration of the study.
Patients with suspected or proven immunocompromised state at screening
History of ongoing, chronic, or major recurrent infectious disease, at the discretion of the investigator, at the start of screening.
Use of any biologic drugs targeting the immune system within 26 weeks of Day 1
Multi-vessel Coronary Artery Bypass Graft (CABG) surgery within the past 6 months prior to the start of screening.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DFV890Oral film-coated tablets of DFV890 once daily	Drug	Treatment Sequence 1, Treatment sequence 2, Treatment sequence 3
DFV890 PlaceboOral film-coated tablets of DFV890 placebo once daily	Drug	Treatment Sequence 1, Treatment sequence 2, Treatment sequence 4

Primary outcome

Ratio to Baseline Serum Levels of IL-6 for DFV890 Based on an Emax Model
Time frame: Baseline (before first dose of study drug), 3 weeks after the start of a dosing period for DFV890 (between Day 22 and Day 85, depending on treatment sequence assignment)
Serum levels of IL-6 at 3 weeks after the start of a dosing period for DFV890. The circulating serum levels of the cytokine IL-6 were measured by a validated enzyme-linked immunosorbent assay (ELISA) assay at a qualified vendor.The Emax model selected for IL-6 analysis was a model with 2 covariates (IL-6 baseline and bodyweight) and 1 random effect.
Ratio to Baseline Serum Levels of IL-18 for DFV890 Based on an Emax Model
Time frame: Baseline (before first dose of study drug), 3 weeks after the start of a dosing period for DFV890 (between Day 22 and Day 85, depending on treatment sequence assignment)
Serum levels of IL-18 at 3 weeks after the start of a dosing period for DFV890. The circulating serum levels of the cytokine IL-18 were measured by a validated enzyme-linked immunosorbent assay (ELISA) assay at a qualified vendor.The Emax model selected for IL-18 analysis was a model with 2 covariates (IL-18 baseline and bodyweight) and 1 random effect.

1 secondary outcome

Trough Plasma Concentration (Ctrough)
Time frame: After the last dose of each 3-week dosing period: Day 22 pre-dose, Day 43 pre-dose, Day 64 pre-dose, or Day 85, depending on treatment sequence assignment

Results and safety

Results posted to the registry on 27 Mar 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment Sequence 1	10	10
Treatment Sequence 2	10	9
Treatment Sequence 3	2	1
Treatment Sequence 4	2	2

Primary outcome: Ratio to Baseline Serum Levels of IL-6 for DFV890 Based on an Emax Model

Time frame: Baseline (before first dose of study drug), 3 weeks after the start of a dosing period for DFV890 (between Day 22 and Day 85, depending on treatment sequence assignment). Geometric mean (80% Confidence Interval). Unit: ratio serum levels of IL-6

Measure	DFV890 10 mg n = 10	DFV890 25 mg n = 19	DFV890 50 mg n = 8	DFV890 100 mg n = 19	Placebo n = 20
Value	0.7191 (0.6003 to 0.8615)	0.5478 (0.4600 to 0.6523)	0.4512 (0.3817 to 0.5333)	0.3901 (0.3227 to 0.4717)	1.0828 (0.9022 to 1.2994)

DFV890 10 mg vs Placebo: Ratio of the Geometric Mean: 0.6642 (80% CI 0.5688 to 0.7755), p = 0.0011, Emax model
DFV890 25 mg vs Placebo: Ratio of the Geometric Mean: 0.5059 (80% CI 0.4279 to 0.5982), p < 0.0001, Emax model
DFV890 50 mg vs Placebo: Ratio of the Geometric Mean: 0.4167 (80% CI 0.3558 to 0.4880), p < 0.0001, Emax model

Population analysed: Participants in the pharmacodynamic (PD) analysis set with available data for the outcome measure.

Primary outcome: Ratio to Baseline Serum Levels of IL-18 for DFV890 Based on an Emax Model

Measure	DFV890 10 mg n = 10	DFV890 25 mg n = 19	DFV890 50 mg n = 8	DFV890 100 mg n = 19	Placebo n = 20
Value	0.9334 (0.8876 to 0.9816)	0.8944 (0.8513 to 0.9396)	0.8676 (0.8269 to 0.9103)	0.8481 (0.8055 to 0.8930)	0.9956 (0.9457 to 1.0482)

DFV890 10 mg vs Placebo: Ratio of the Geometric Mean: 0.9375 (80% CI 0.9058 to 0.9703), p = 0.0108, Emax model
DFV890 25 mg vs Placebo: Ratio of the Geometric Mean: 0.8983 (80% CI 0.8645 to 0.9334), p = 0.0007, Emax model
DFV890 50 mg vs Placebo: Ratio of the Geometric Mean: 0.8714 (80% CI 0.8394 to 0.9046), p < 0.0001, Emax model

Population analysed: Participants in the pharmacodynamic (PD) analysis set with available data for the outcome measure.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
DFV890 10 mg	0 of 12 (0%)	2 of 12 (16.7%)	0 of 12
DFV890 25 mg	0 of 21 (0%)	2 of 21 (9.5%)	0 of 21
DFV890 50 mg	2 of 10 (20%)	2 of 10 (20%)	0 of 10
DFV890 100 mg	0 of 20 (0%)	0 of 20 (0%)	0 of 20
Placebo Sessions	0 of 28 (0%)	4 of 28 (14.3%)	0 of 28
Placebo Participants	0 of 22 (0%)	4 of 22 (18.2%)	0 of 22
DFV890 10 mg Follow-up	0 of 1 (0%)	1 of 1 (100%)	0 of 1
DFV890 25 mg Follow-up	0 of 1 (0%)	1 of 1 (100%)	0 of 1
DFV890 100 mg Follow-up	0 of 20 (0%)	0 of 20 (0%)	0 of 20
Placebo Follow-up	0 of 2 (0%)	0 of 2 (0%)	0 of 2

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
A Plain Language Trial Summary is available on www.novctrd.comLink provided by the sponsor.
Individual participant dataSharing planned: Yes. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Novartis Pharmaceuticals study director

Novartis Pharmaceuticals

7 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing DFV890 in people with Coronary Heart Disease, run by Novartis Pharmaceuticals at 7 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ratio to Baseline Serum Levels of IL-6 for DFV890 Based on an Emax Model (time frame: Baseline (before first dose of study drug), 3 weeks after the start of a dosing period for DFV890 (between Day 22 and Day 85, depending on treatment sequence assignment)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06031844.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.